The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Nathaniel Jenkins
Study ID
NCT06454344
Status
Recruiting
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Conditions

  • Adverse Childhood Experiences
  • Endothelial Dysfunction
  • Inflammation
  • Oxidative Stress
  • Psychological Trauma
  • Psychosocial Stressor
  • Sleep
  • Sleep Disturbance
  • Vascular Dilatation

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • Cognitive Behavioral Therapy for Insomnia (CBT-i) — BEHAVIORAL
    CBT-I is a structured program with a robust empirical evidence supporting its efficacy for improving sleep quality and quantity. The cognitive component of CBT-I teaching individuals how to recognize and change the beliefs they hold about sleep that negatively impact sleep, such as negative thoughts and emotions. The behavioral component includes several strategies to help improve sleep, including: improved sleep hygiene, improving the sleep environment, relaxation training, stimulus control therapy (consistent wake/sleep times, using the bed only for sleep, etc), and sleep restriction. Sleep restriction consists of reducing the time spend in bed initially to increase sleep drive in subsequent nights. Once sleep has improved, the time in bed is gradually increased again.

Study Details

The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function. In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim. In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.

Key Dates

Start date
May 1, 2024
Status verified
Dec 2025
Primary completion
Dec 15, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cognitive Behavioral Therapy for Insomnia (CBT-i)
  • No Intervention: Waitlist Control

Primary Outcome Measure

Vascular Endothelial Function [ Time Frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Integrative Laboratory of Applied Physiology and Lifestyle MedicineIowa CityIowa52242
Nathaniel Jenkins, PhD
3194673091

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By research site
Integrative Laboratory of Applied Physiology and Lifestyle Medicine· Iowa City, IA

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